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Not yet recruiting NCT04530058

The Effects of Metformin on Morbidity and Mortality in Elderly Patients

Phase II Interventional Burns

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metformin, Placebos.
Who it may be relevant to
Registry conditions: Burns. Basic parameters: 60 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effects of Metformin on Morbidity and Mortality in Elderly Patients- a Prospective Randomized Control Trial (RCT)

Overview

Elderly patients have an increased susceptibility to burns and a substantial mortality that has not significantly changed over the last three decades. Elderly burn patients not only have an augmented response to burn but also express a prolonged hypermetabolic response.Glucose metabolism with insulin resistance is a hypermetabolic response pathway that profoundly affects post-burn outcomes. The aim if this study is to determine whether metformin can improve morbidity and mortality in elderly burn patients. The investigators hypothesize that metformin will improve clinical outcomes and mortality of elderly burn patients by alleviating the complex inflammatory and hypermetabolic responses after burn.

Interventions

  • Drug Metformin
    Metformin 500 mg twice a day, administered orally or via gastric tube.
  • Drug Placebos
    Placebo twice a day, administered orally or via gastric tube.

Primary outcome measures

  • Record mortality [Time frame: Acute hospitalization up to one year post burn.]
  • Record the episodes of sepsis. [Time frame: daily until discharge (1-4 months post admission depending on severity of injury)]]
  • Record episodes of infection. [Time frame: daily until discharge (1-4 months post admission depending on severity of injury)]]
  • Record episodes of pneumonia. [Time frame: daily until discharge (1-4 months post admission depending on severity of injury)]]
  • Organ function - Alkaline phosphatase (ALP) [Time frame: twice weekly until discharge (1-4 months post admission depending on severity of injury)]]
  • Organ function - Alanine transaminase (ALT) [Time frame: twice weekly until discharge (1-4 months post admission depending on severity of injury)]]
  • Organ function - Bilirubin [Time frame: twice weekly until discharge (1-4 months post admission depending on severity of injury)]]
  • Organ function - Blood Urea Nitrogen (BUN) [Time frame: twice weekly until discharge (1-4 months post admission depending on severity of injury)]]
  • Organ function - Creatinine [Time frame: twice weekly until discharge (1-4 months post admission depending on severity of injury)]]
Secondary outcome measures (2)
  • Measures of steady-state resting energy expenditure (REE) [Time frame: weekly until discharge if a patient is intubated and ventilated (1-4 months post admission depending on severity of injury)]]
  • Perform oral glucose tolerance test [Time frame: once at discharge from hospital (1-4 months post admission depending on the severity of injury)]]

Eligibility criteria

Inclusion criteria

  • Aged 60 - 99 years of age.
  • ≥5% total body surface area (TBSA) burn.
  • Admitted to burn center ≤ 120 hours post-burn injury.
  • At least one surgical intervention likely required.
  • Provide written informed consent.

Exclusion criteria

  • Death upon admission.
  • Decision not to treat due to burn injury severity.
  • Presence of anoxic brain injury that is not expected to result in complete recovery.
  • Pre-existing renal failure (eGFR is < 30 mL/min).
  • Severe liver disease (Child-Pugh C).
  • Pre-existing insulin-dependent type II diabetes.
  • Clinical contraindication to give metformin.
  • Allergy to metformin or insulin.
  • History of lactic acidosis while receiving metformin treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Hamilton Health Sciences Centre — Hamilton

Identifiers

NCT: NCT04530058 · 15230

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗